Phase
Condition
Glaucoma
Open Angle Glaucoma
Treatment
Combined cataract surgery with Hydrus microstent
Combined cataract surgery with iStent Inject W
Clinical Study ID
Ages > 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
>60 years or older
Visually significant cataract
Mild to moderate primary open angle glaucoma controlled on medications
undergoing cataract surgery with lens implantation and concurrent microstentplacement
IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s)
CCT 480 to 620μm
No prior ocular surgery including corneal refractive surgery
No SLT within 6 months of baseline visit, no history of intracameral glaucoma drugeluting implants
Visual field mean deviation ≤ -12 dB
Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8
Exclusion
Exclusion Criteria:
Prior intraocular surgery
Visual field MD ≥ -12 dB
secondary glaucoma including uveitis, traumatic, malignant, neovascular, andcongenital glaucoma.
Glaucoma related to elevated episcleral venous pressure including Sturge-Webersyndrome, thyroid eye disease, orbital tumor, and etc.
Uncontrolled intraocular pressure on maximum tolerated medical therapy;
Unable to perform wash-out IOP
Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), otherangle abnormalities including angle closure glaucoma
Corneal disease or dystrophy
Pathological myopia with degeneration that affects diagnostic imaging
Clinically significant ocular pathology or degenerative diseases that affect vision,visual field, or optical coherence tomography of optic nerve.
Inability to perform reliable Visual Field and optical coherence tomography.
Study Design
Connect with a study center
Diablo Eye Associates
Walnut Creek, California 94598
United StatesSite Not Available
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